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Arrow Central Venous Catheter Manual

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Central Venous Catheter (CVC) Product
Rx only.
Indications:
The Arrow CVC is intended to provide short-term (< 30 days) central venous access for treatment of
diseases or conditions requiring central venous access, including, but not limited to the following:
Lack of usable peripheral IV sites
Central venous pressure monitoring
Total parenteral nutrition (TPN)
Infusions of fl uids, medications, or chemotherapy
Frequent blood sampling or receiving blood transfusions/blood products
See additional labeling for product specifi c indications.
Contraindications:
None known. See additional labeling for product specifi c contraindications.
General Warnings and Cautions
Warnings:
1. Sterile, Single use: Do not reuse, reprocess or resterilize. Reuse of device creates a potential
risk of serious injury and/or infection which may lead to death.
2. Read all package insert warnings, precautions and instructions prior to use. Failure to do so
may result in severe patient injury or death.
3. Do not place catheter into or allow it to remain in the right atrium or right ventricle. X-ray
exam or other method in compliance with institutional policies and procedures must
show catheter tip located in lower 1/3 of the Superior Vena Cava (SVC), in accordance with
institutional guidelines.
4. Clinicians must be aware of potential entrapment of the guidewire by any implanted device
in circulatory system. It is recommended that if patient has a circulatory system implant,
catheter procedure be done under direct visualization to reduce risk of guidewire entrapment.
5. Do not use excessive force when introducing guidewire or tissue dilator as this can lead to
vessel perforation, bleeding, or component damage.
6. Passage of guidewire into the right heart can cause dysrhythmias, right bundle branch
block, and a perforation of vessel, atrial or ventricular wall.
7. Do not apply excessive force in placing or removing catheter or guidewire. Excessive
force can cause component damage or breakage. If damage is suspected or withdrawal
cannot be easily accomplished, radiographic visualization should be obtained and further
consultation requested.
8. Using catheters not indicated for high pressure injection for such applications can result in
inter-lumen crossover or rupture with potential for injury.
9. Do not secure, staple and/or suture directly to outside diameter of catheter body or
extension lines to reduce risk of cutting or damaging the catheter or impeding catheter
fl ow. Secure only at indicated stabilization locations.
10. Air embolism can occur if air is allowed to enter a central venous access device or vein. Do
not leave open needles or uncapped, unclamped catheters in central venous puncture site.
Use only securely tightened Luer-Lock connections with any central venous access device to
guard against inadvertent disconnection.
11. Clinicians should be aware that slide clamps may be inadvertently removed.
12. Clinicians must be aware of complications associated with central venous catheters
including, but not limited to:
cardiac tamponade
catheter embolism
secondary to vessel,
catheter occlusion
atrial, or ventricular
thoracic duct
perforation
laceration
pleural (i.e.,
bacteremia
pneumothorax)
septicemia
and mediastinal
thrombosis
injuries
inadvertent arterial
air embolism
puncture
Cautions:
1. Do not alter the catheter, guidewire or any other kit/set component during insertion, use or
removal.
2. Procedure must be performed by trained personnel well versed in anatomical landmarks, safe
technique and potential complications.
3. Use standard precautions and follow established institutional policies and procedures.
4. Some disinfectants used at catheter insertion site contain solvents which can weaken the
catheter material. Alcohol, acetone, and polyethylene glycol can weaken the structure of
polyurethane materials. These agents may also weaken the adhesive bond between catheter
stabilization device and skin.
Do not use acetone on catheter surface.
Do not use alcohol to soak catheter surface or allow alcohol to dwell in a catheter lumen to
restore catheter patency or as an infection prevention measure.
Do not use polyethylene glycol containing ointments at insertion site.
Take care when infusing drugs with a high concentration of alcohol.
Allow insertion site to dry completely prior to applying dressing.
5. Ensure catheter patency prior to use. Do not use syringes smaller than 10 mL (a fl uid fi lled
1 mL syringe can exceed 300 psi) to reduce risk of intraluminal leakage or catheter rupture.
6. Minimize catheter manipulation throughout procedure to maintain proper catheter tip position.
nerve injury
hematoma
hemorrhage
fi brin sheath formation
exit site infection
vessel erosion
catheter tip malposition
dysrhythmias
1
Kits/Sets may not contain all accessory components detailed in these
instructions for use. Become familiar with instructions for individual
component(s) before beginning the procedure.
A Suggested Procedure: Use sterile technique.
Prep Puncture Site:
1. Position patient as appropriate for insertion site.
• Subclavian or Jugular approach: Place patient in slight Trendelenburg position as tolerated to
reduce risk of air embolism and enhance venous fi lling.
• Femoral approach: Place patient in supine position.
2. Prepare clean skin with an appropriate antiseptic agent.
3. Drape puncture site.
4. Administer local anesthetic per institutional policies and procedures.
5. Dispose of needle.
SharpsAway II™ Locking Disposal Cup (where provided):
The SharpsAway II Locking Disposal Cup is used for disposal of needles (15 Ga. - 30 Ga.).
Using one-handed technique, fi rmly push needles into disposal cup holes (refer to Figure 1).
Once placed into disposal cup, needles will be automatically secured in place so that they cannot be reused.
Caution: Do not attempt to remove needles that have been placed into SharpsAway II
Locking Disposal Cup. These needles are secured in place. Damage may occur to needles if
they are forced out of disposal cup.
Where provided, a foam SharpsAway® system may be utilized by pushing needles into foam after use.
Caution: Do not re-use needles after they have been placed into the foam SharpsAway
system. Particulate matter may adhere to needle tip.
Prepare Catheter:
6. Flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s).
7. Clamp or attach Luer-Lock connector(s) to extension line(s) to contain saline within lumen(s).
8. Leave distal extension line uncapped for guidewire passage.
Warning: Do not cut catheter to alter length.
Gain Initial Venous Access:
Echogenic Needle (where provided):
An echogenic needle is used to allow access to the vascular system for the introduction of a guidewire to
facilitate catheter placement. The needle tip is enhanced for approximately 1 cm for clinician to identify
exact needle tip location when puncturing the vessel under ultrasound.
Protected Needle/Safety Needle (where provided):
A protected needle/safety needle should be used in accordance with manufacturer's instructions for use.
Arrow® Raulerson Syringe (where provided):
Arrow Raulerson Syringe is used in conjunction with Arrow Advancer for guidewire insertion.
9. Insert introducer needle or catheter/needle with attached syringe or Arrow Raulerson Syringe
(where provided) into vein and aspirate.
Warning: Do not leave open needles or uncapped, unclamped catheters in central venous
puncture site. Air embolus can occur with these practices.
Caution: Do not reinsert needle into introducer catheter (where provided) to reduce risk of
catheter embolus.
Verify Venous Access:
Utilize one of the following techniques to verify venous access because of the potential for inadvertent
arterial placement:
Central Venous Waveform:
• Insert fl uid primed blunt tip pressure transduction probe into rear of plunger and through
valves of Arrow Raulerson Syringe and observe for central venous pressure waveform.
◊ Remove transduction probe if using Arrow Raulerson Syringe.
Pulsatile Flow (if hemodynamic monitoring equipment is not available):
• Use transduction probe to open syringe valving system of Arrow Raulerson Syringe and observe
for pulsatile fl ow.
• Disconnect syringe from needle and observe for pulsatile fl ow.
Warning: Pulsatile fl ow is usually an indicator of inadvertent arterial puncture.
Caution: Do not rely on blood aspirate color to indicate venous access.
Figure 1

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  Summary of Contents for Arrow Central Venous Catheter

  • Page 1 Kits/Sets may not contain all accessory components detailed in these instructions for use. Become familiar with instructions for individual The Arrow CVC is intended to provide short-term (< 30 days) central venous access for treatment of component(s) before beginning the procedure.
  • Page 2 “locked” through Luer-Lock connector(s) using standard institutional policies and procedures. • Place tip of Arrow Advancer – with “J” retracted – into the hole in rear of Arrow Raulerson Syringe • Slide clamp(s) are provided on extension lines to occlude fl ow through each lumen during line plunger or introducer needle (refer to Figure 3).
  • Page 3 Ne pas utiliser de pommades à base de polyéthylèneglycol au niveau du site d’insertion. • Prendre des précautions lors de la perfusion de médicaments contenant des concentrations Le CVC Arrow est indiqué pour un accès veineux central à court terme (moins de 30 jours) dans le élevées d’alcool. •...
  • Page 4 25. Utiliser un stabilisateur de cathéter, un clamp et le dispositif de fi xation ainsi que des agrafes ou • Placer l’ e xtrémité de l’Arrow Advancer, avec le J rengainé, dans l’ o rifi ce situé à l’arrière du piston de des sutures (si fournies).
  • Page 5 • Die Katheteroberfl äche darf nicht in Alkohol eingeweicht werden und Alkohol darf auch nicht Der Arrow ZVK ist für einen kurzzeitigen (<  30 Tage) zentralen Venenzugang zur Behandlung von zur Wiederherstellung der Katheterdurchgängigkeit oder als Infektionsprophylaxe in einem Krankheiten oder Beschwerden, die einen zentralen Zugang zur Vene erfordern, bestimmt, unter Katheterlumen verweilen.
  • Page 6 25. Eine Katheterstabilisierungsvorrichtung, eine Katheterklemme und einen Halter, Klammern oder • Die Spitze des Arrow Advancer – mit zurückgezogener „J“-Spitze – in die Öff nung auf der Rückseite Nähte (sofern vorhanden) verwenden. • Als Primärnahtstelle die dreieckige Anschlussstelle mit Seitenfl ügeln verwenden.
  • Page 7 Non usare alcool per bagnare la superfi cie del catetere né consentire la permanenza di alcool Il catetere venoso centrale Arrow è previsto per consentire l’accesso al sistema venoso centrale a breve all’interno del lume del catetere allo scopo di ripristinarne la pervietà o come misura atta alla termine (<30 giorni) per il trattamento di patologie o condizioni che richiedano tale tipo di accesso...
  • Page 8 Avvertenza – Prima dell’infusione attraverso il lume, aprire il morsetto scorrevole per Il dispositivo Arrow Advancer serve per raddrizzare la punta a “J” del fi lo guida per l’introduzione del fi lo ridurre il rischio di danneggiare la prolunga a causa di una pressione eccessiva.
  • Page 9 Nie wolno stosować acetonu na powierzchni cewnika. • Nie używać alkoholu do namaczania powierzchni cewnika ani zezwalać na pozostawanie Centralny cewnik żylny Arrow jest przeznaczony do zapewniania krótkotrwałego (< 30 dni) dostępu alkoholu w kanale cewnika w celu jego udrożnienia lub jako środek zapobiegający zakażeniu. •...
  • Page 10 Przestroga: Przez cały czas trwania zabiegu należy ograniczyć do minimum manipulacje 11. Podnieść kciuk i odciągnąć przyrząd Arrow Advancer na około 4 – 8 cm od strzykawki Arrow cewnikiem, aby zachować prawidłowe położenie końcówki cewnika. Raulerson lub igły wprowadzającej. Opuścić kciuk na przyrząd Arrow Advancer i, nadal mocno Urządzenie do stabilizacji cewnika (jeśli jest dostarczone w zestawie):...
  • Page 11: Contra-Indicações

    5. Antes da utilização, certifi que-se de que o cateter está permeável. Não utilize seringas O CVC Arrow está indicado para a disponibilização de acesso venoso central a curto prazo (< 30 dias) menores que 10 ml (uma seringa de 1 ml cheia de líquido pode exceder 2068,4 kPa) para no tratamento de doenças ou de condições que exigem acesso venoso central incluindo, entre outras...
  • Page 12 • Coloque a ponta do Arrow Advancer – com o “J” retraído – no orifício na parte de trás do êmbolo da Fixe o cateter: seringa ou agulha introdutora Arrow Raulerson (consultar a Figura 3).
  • Page 13 • Введите заполненную жидкостью иглу контроля давления (с притупленным кончиком) 4. Некоторые средства дезинфекции, используемые в месте введения катетера, содержат в заднюю часть поршня и через клапаны шприца Arrow Raulerson и наблюдайте кривую растворители, способные снизить прочность материала катетера. Спирт, ацетон и...
  • Page 14 Закрепите катетер Arrow Raulerson или в пункционную иглу (см. рисунок 3). 10. Продвиньте проводник в шприц Arrow Raulerson примерно на 10 см, так, чтобы он прошел 25. Используйте фиксатор катетера, зажим и защелку катетера, скобки или швы (при наличии). • Первичный шов накладывается на треугольную соединительную втулку с боковыми...
  • Page 15 • vodila. plevralne (t.j. okužba izstopišča • septikemija pnevmotoraks) 9. Uvajalno iglo ali sklop katetra in igle s pritrjeno brizgo ali brizgo Arrow Raulerson (če je priložena) • • erozija žile vstavite v žilo in aspirirajte. in mediastinalne tromboza •...
  • Page 16 S palcem izvlecite „J“ (glejte sliko 2). • Konico potiskala Arrow Advancer – ko je „J“ izvlečen – namestite v odprtino na zadnji strani bata svetlino, ko je treba zamenjati linijo ali priključek luer-lock. brizge Arrow Raulerson ali uvajalne igle (glejte sliko 3).
  • Page 17 Estos agentes también pueden debilitar la unión adhesiva entre el dispositivo de estabilización El CVC Arrow está indicado para proporcionar acceso venoso central a corto plazo (< 30 días) para del catéter y la piel.
  • Page 18 Asegure el catéter: Arrow Advancer se utiliza para enderezar la punta en «J» de la guía para la introducción de la guía en 25. Utilice una pinza y una sujeción de catéter, un dispositivo de estabilización del catéter, grapas o la jeringa Raulerson de Arrow o en una aguja.
  • Page 19 Indikationer: kan försvaga strukturen hos polyuretanmaterial. Dessa medel kan även försvaga vidhäftningen mellan kateterstabiliseringsanordningen och huden. Arrow central venkateter är avsedd för att tillhandahålla kortvarig (<30 dagar) central venåtkomst för • Använd inte aceton på kateterns yta. behandling av sjukdomar eller tillstånd som kräver central venåtkomst, inklusive, men inte begränsat •...
  • Page 20 Varning: Skjutklämman ska öppnas före infusion genom lumen för att minska risken för att Arrow Advancer (i förekommande fall): förlängningsslangen skadas till följd av ett alltför kraftigt tryck. Arrow Advancer används för att räta ut ledarens J-spets för införing av ledaren i Arrow Raulerson- Fäst katetern: sprutan eller en nål.
  • Page 21 • Kateter yüzeyini batırmak için alkol kullanmayın veya kateter açıklığını tekrar oluşturmak Arrow SVK aşağıdakiler dahil ama bunlarla sınırlı olmamak üzere santral venöz erişim gerektiren veya bir enfeksiyonu önleme yolu olarak kateter lümeninde alkol kalmasına izin vermeyin. hastalıklar veya durumların tedavisi için kısa süreli (< 30 gün) santral venöz erişim sağlamak üzere •...
  • Page 22 • Gerektiğinde sekonder sütür bölgesi olarak kateter klempi ve tutturucu kullanın. 11. Başparmağı kaldırın ve Arrow Advancer’ı Arrow Raulerson Şırıngası veya introduser iğneden yaklaşık 4 - 8 cm uzağa çekin. Başparmağı Arrow Advancer üzerine indirin ve kılavuz teli sıkıca Dikkat: Uygun kateter ucu pozisyonunu devam ettirmek üzere işlem boyunca kateter tutarken kılavuz teli daha fazla ilerletmek üzere Arrow Advancer ve kılavuz tel tertibatını...
  • Page 24 Arrow International, Inc. Subsidiary of Telefl ex Incorporated Telefl ex Medical IDA Business and Technology Park 2400 Bernville Road | Reading, PA 19605 USA Dublin Road, Athlone, 1-800-523-8446 | 1-610-378-0131 Co. Westmeath, Ireland...