Bard PowerPICC SOLO 2 Instructions For Use Manual

Brand: Bard

Model: PowerPICC SOLO 2

Type: Instructions For Use Manual

Power. Saline. One.*

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Türkçe 61

PowerPICC SOLO*

Catheter

Polyurethane Radiology Valved PICC with Microintroducer Set - Instructions for use

Cathéter PowerPICC SOLO*

CCIP de radiologie en polyuréthane avec valve + kit microintroducteur - Mode d’

emploi

PowerPICC SOLO*

-Katheter

Polyurethan-PICC für die Radiologie mit Ventil und Microintroducer-Set - Gebrauchsanweisung

Catetere PowerPICC SOLO*

PICC valvolato in poliuretano per uso in radiologia con kit di microintroduzione - Istruzioni per l’uso

PowerPICC SOLO*

Catéter

PICC con válvula de poliuretano con set de microcanalización para radiología - Instrucciones de uso

PowerPICC SOLO*

Katheter

Polyurethaan Radiologie Valved PICC met Microintroducer Set - Gebruiksaanwijzing

Cateter PowerPICC SOLO*

PICC Radiológico de Poliuretano Com Válvula e Conjunto de Microintrodutor - Instruções de Utilização

Καθετήρας PowerPICC SOLO*

ΠΕΚΚ βαλβίδων πολυουρεθάνης ακτινολογίας με σετ μικροεισαγωγής - Οδηγίες χρήσης

PowerPICC SOLO*

Kateter

Polyuretan radiologi-ventileret PICC med microintroducer-sæt - Brugsvejledning

PowerPICC SOLO*

kateter

PICC med radiologisk ventil av polyuretan med mikroinförarsats - Bruksanvisning

PowerPICC SOLO*

-katetri

Polyuretaanista valmistettu venttiilillinen PICC ja mikrosisäänviejäsetti radiologiakäyttöön - Käyttöohjeet

PowerPICC SOLO*

Kateter

Polyurethane Radiology Valved PICC with Microintroducer Set (Polyuretan radiologi ventilert PICC med Microintroducer-sett) - Bruksanvisning

PowerPICC SOLO*

Katéter

Poliuretán radiológiai szelepes PICC mikrobevezető készlettel - Használati utasítások

Katétr PowerPICC SOLO*

Catheter

Polyuretanový radiologický PICC (periferně zaváděný centrální katétr) s ventilem se sadou mikrozaváděče - Návod kpoužití

PowerPICC SOLO*

Cewnik

Poliuretanowy cewnik PICC z zaworem i mikrointroducerem – instrukcja użycia

PowerPICC SOLO*

Kateter

Mikrointrodüser Setli Poliüretan Radyoloji Valflı PICC- Kullanım talimatları

PowerPICC SOLO*

катетер

Полиуретановый периферически вводимый центральный венозный катетер с рентгеноконтрастным

клапаном и микроиндьюсером - Инструкции по использованию

Русский 65

Symbols / Symboles / Symbole / Simboli / Símbolos / Symbolen / Símbolos / Σύμβολα / Symboler / Symboler /

Symbolit / Symboler / Jelzések / Symboly / Symbole / Semboller / Символы

Break This Seal / Briser ce cachet / Dieses Siegel brechen / Rompere il sigillo / Romper este sello / Verbreek deze verzegeling / Quebre este selo/

Σπάστε αυτήν τη σφράγιση / Bryd denne forsegling / Bryt förseglingen / Riko tämä sinetti / Bryt denne forseglingen / Fel kell törni a pecsétet /

Otevřete pečeť / Przerwać uszczelnienie / Bu Mührü Bozun/ Сломайте эту пломбу

French Size / Taille French / Größe / Misura French / Tamaño French / maat: Ch. / Tamanho French / Μέγεθος σε French / French størrelse /

Storlek i French / F-koko / French Str. / Fr. méret / Velikost (French) / Rozmiar [F] / French Boyut / / Французский калибр

Contents / Contenu : / Inhalt / Contenuto / Contenidos / Inhoud / Conteúdo / Περιεχόμενα / Indhold / Innehåll / Sisältö / Innhold / Tartalom / Obsah /

Zawartość / İçindekiler / Содержание /

Do not use if package is damaged. / Ne pas utiliser si l’emballage est endommagé. / Nicht verwenden, wenn die Verpackung beschädigt ist. /

Non utilizzare se la confezione è danneggiata. / No usar si el envase está dañado. / Niet gebruiken wanneer de verpakking beschadigd is. /

Não utilizar se a embalagem estiver danicada. / Μην χρησιμοποιείτε το προϊόν εάν η συσκευασία του έχει υποστεί ζημιά. / Må ikke anvendes, hvis

emballagen er beskadiget. / Använd inte produkten om förpackningen är skadad. / Älä käytä, jos pakkaus on vaurioitunut. / Må ikke brukes dersom

pakningen er skadet. / A készüléket ne használja, ha a csomagolása megsérült. / Nepoužívejte, pokud je obal poškozen. / Nie używać, jeśli opak-

owanie jest uszkodzone. / Paket hasarlıysa kullanmayınız.

/ Запрещается использовать, если упаковка повреждена.

Non-pyrogenic / Apyrogène. / Pyrogenfrei. / Apirogeno. / Apirógeno. / Niet-pyrogeen. / Apirogénico. / Μη πυρετογόνο. / Pyrogenfri. / Icke-pyrogen. /

Pyrogeeniton. / Pyrogenfri. / Nem pirogén. / Apyrogenní. / Produkt niepirogenny. / Pirojenik değildir. / Апирогенно

The Greendot / Le Point vert / Der Grüne Punkt / The Greendot / El punto verde / De groene stip / Ponto verde / Η Πράσινη Κουκκίδα / Den grønne

prik / Grön punkt / Grønt punkt / Vihreä piste / A zöld pont / Zelený bod / Zielony Punkt / Yeşil nokta işareti / Зеленая точка (символ вторсырья) /

Greendot / Greendot

Recyclable Polyethylene Terephthalate / Polyéthylène téréphthalate recyclable / Recyclingfähiges Polyethylenterephthalat / Polietilentereftalato

riciclabile / Polietilentereftalato reciclable / Recyclebaar polyethyleenterefthalaat / Tereftalado de polietileno reciclável / Ανακυκλώσιμο τερεφθαλικό

πολυαιθυλένιο / Polythylen-terephthalat til genbrug / Återanvändbar polyetylentereftalat / Kierrätettävä polyetyleenitereftalaatti / Resirkulerbar

polyetylentereftalat / Újrahasznosítható polietilén tereftalát / Recyklovatelný polyetylentereftalát / Tereftalan polietylenu do wtórnego wykorzystania

/ Geri Dönüşümlü Polietilen Tereftalat / Пригодный для вторичной переработки полиэтилен-терефталат

Microintroducer / Micro-introducteur / Mikroeinführungsbesteck / Microintroduttore / Microintroductor / Micro-introducer / Micro introdutor /

Μικροεισαγωγέας / Mikrointroducer / Mikroinförare / Mikrosisäänviejä / Mikrointroduser / Mikrobevezető / Mikrozavaděč / Mikrointroducer / Mikro

Yerleştirici / Микроинтродьюсер

Single Lumen / Lumière unique / Einlumig / Lume singolo / Un lumen / Enkel lumen / Lúmen simples / Μονός αυλός / Enkelt lumen / En lumen /

Yksilumeninen / Enkellumen / Egyszeres lumen / Jednolumenový katetr / Jednokanałowy / Tek Lümen / Одноканальный

Dual Lumen / Lumière double / Doppellumig / Lume doppio / Dos lúmenes / Dubbel lumen / Lúmen duplo / Διπλός αυλός / Dobbelt lumen / Två

lumen / Kaksilumeninen / Dobbellumen / Kettős lumen / Dvoulumenový katetr / Dwukanałowy / Çift Lümen / Двухканальный

Triple Lumen / Lumière triple / Dreilumig / Lume triplo / Tres lúmenes / drie lumina / Lúmen triplo / Τριπλός αυλός / Tredobbelt lumen / Tre lumen /

Kolmelumeninen / Tredobbellumen / Háromszoros lumen / Trojlumenový katetr / Trójkanałowy / Üçlü Lümen / Трехканальный

Length / Longueur / Länge / Lunghezza / Longitud / Lengte / Comprimento / Μήκος / Længde / Längd / Pituus / Lengde / Hossz / Délka / Długość /

Uzunluk / Длина

This product and package do not contain natural rubber latex / Ce produit et son emballage ne contiennent aucune trace de latex en caoutchouc

naturel / Dieses Produkt und die Verpackung enthalten kein Naturlatex / Il prodotto e la confezione non contengono lattice di gomma naturale / Este

producto y su embalaje no contienen látex de goma natural / Dit product en de verpakking bevatten geen natuurlijke rubberlatex / Este produto

e respectiva embalagem não contêm látex de borracha natural / Το παρόν προϊόν και η συσκευασία δεν περιέχουν λάτεξ από φυσικό καουτσούκ /

Dette produkt indeholder ikke naturgummilatex / Denna produkt och förpackning innehåller inte naturligt gummilatex / Tämä tuote ja sen pakkaus

eivät sisällä luonnonkumilateksia / Dette produktet og emballasjen inneholder ikke naturlig gummilateks / Ez a termék és csomagolása nem

tartalmaz természetes gumilatexet / Výrobek a obal neobsahují přírodní kaučukový latex / Produkt i opakowanie nie zawierają kauczuku lateksu

naturalnego / Bu ürün ve ambalaj, doğal lastik lateks içermez / Данное изделие и его упаковка не содержат натурального латекса

Does Not Contain DEHP / Ne contient pas de DEHP / Enthält kein DEHP / Non contiene DEHP / Nocontienen DEHP / Bevat geen diethylhexylftalaat

(DEHP) / Não contém DEHP / Δεν περιέχει DEHP / Indeholder ikke DEHP / Innehåller ej DEHP / Ei sisällä DEHP:tä / Inneholder ikke DEHP / Nem

tartalmaz DEHP-t (dietil-hexil-ftalátot) / Neobsahuje DEHP / Niezawiera DEHP / DEHP içermez / Не содержит диэтилгексилфталат (DEHP)

After use, this product may be a potential biohazard. Handle and dispose of in accordance with local, state and federal laws and regulations.

/ Après utilisation, ce produit peut représenter un danger potentiel pour l’environnement. Le manipuler et le détruire conformément aux pratiques

médicales reconnues et aux règlements et lois locaux, nationaux et fédéraux applicables. / Nach dem Gebrauch kann dieses Produkt eine biologische

Gefahrenquelle darstellen. Gemäß den anerkannten medizinischen Vorschriften und den geltenden örtlichen, Landes- und Bundesgesetzen und

Bestimmungen handhaben und entsorgen. / Dopo l’uso questo prodotto può rappresentare un potenziale rischio biologico. Manipolare ed elimin-

are secondo la pratica medica corrente o secondo le leggi e le norme locali, statali o federali applicabili. / Después de su uso, este producto puede

suponer un peligro biológico en potencia. Manipúlelo y deséchelo conforme a la práctica médica aceptada y las leyes y reglamentos locales, estatales

y federales. / Na gebruik kan dit product een biologisch gevaar voor mens en milieu opleveren. Het dient te worden gebruikt en weggegooid zoals al-

gemeen gebruikelijk in de medische praktijk en conform de van toepassing zijnde plaatselijke en nationale wetten en voorschriften. / Após utilização,

este produto pode constituir um risco biológico potencial. Manuseie-o e elimine-o de acordo com as práticas médicas aprovadas e com a legisla-

ção e regulamentos locais, estatais e federais. / Μετά από τη χρήση, το παρόν προϊόν ενδέχεται να αποτελεί δυνάμει βιολογικό κίνδυνο. Χειριστείτε

και απορρίψτε σύμφωνα με τους κατά τόπους, κρατικούς και ομοσπονδιακούς νόμους και κανονισμούς. / Efter brug kan dette produkt udgøre en

potentiel biologisk risiko. Skal håndteres og bortskaffes i overensstemmelse med accepterer medicinsk praksis og i henhold til gældende lokale og

nationale samt EU-lovgivning og direktiver. / Efter användning kan den här produkten utgöra en eventuell biologisk risk. Hantera och kasta den enligt

accepterad medicinsk praxis och tillämpliga lagar och föreskrifter. / Käytön jälkeen tuote voi olla tartuntavaarallinen. Välinettä on käsiteltävä ja se on

hävitettävä laitoksen käytännön ja soveltuvien ohjeiden ja määräysten mukaisesti. / Etter bruk, kan dette produktet utgjøre en potensiell biofare. Skal

håndteres og avhendes i henhold til godkjent medisinsk praksis og gjeldende lokale, statlige og føderale lover og regelverk. / Használat után a termék

potenciális biológiai veszélyt jelenthet. Kezelése és megsemmisítése során a bevált orvosi gyakorlatnak és a vonatkozó helyi, állami és szövetségi

törvényeknek és rendelkezéseknek megfelelően kell eljárni. / Tento výrobek představuje po použití potenciální biologické riziko. S výrobkem manipu-

lujte a zlikvidujte jej v souladu se zavedenou lékařskou praxí a s příslušnými státními a federálními zákony a předpisy. / Po użyciu produkt stanowi

źródło potencjalnego zagrożenia biologicznego. Należy go stosować i utylizować zgodnie z przyjętymi procedurami medycznymi oraz odpowiednimi

zarządzeniami i przepisami prawa. / Bu ürün, kullanıldıktan sonra potansiyel bir biyolojik tehlike haline gelebilir. Tıbbi uygulamalar ve uygulanan yerel,

ulusal yasalar ve düzenlemeler doğrultusunda kullanınız ve imha ediniz. / После использования данное изделие может представлять потенциальную

биологическую опасность. Обращайтесь и утилизируйте в соответствии с местными, государственными и федеральными законами.

Intended for single use. DO NOT REUSE. Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural

integrity and/or essential material and design characteristics of the device, which may lead to device failure and/or lead to injury, illness or

death of the patient. / Conçu pour un usage unique. NE PAS RÉUTILISER. Le réemploi et/ou le reconditionnement peut entraîner un risque d’infection

au patient ou à l’utilisateur, compromettre l’intégrité structurelle et/ou les caractéristiques élémentaires de la conception et des matériaux de

fabrication du dispositif, ce qui peut entraîner la défaillance du dispositif et/ou donner lieu à une lésion, une maladie, ou au décès du patient. / Für den

Einmalgebrauch bestimmt. NICHT WIEDERVERWENDEN. Durch Wiederverwenden oder Umpacken kann ein Infektionsrisiko für Patient oder Benutzer

entstehen, können die strukturelle Integrität und/oder wesentliche Material- und Konstruktionsmerkmale des Geräts beeinträchtigt werden, was zu

einer Störung des Geräts und/oder zu Verletzung, Erkrankung oder zum Tode des Patienten führen kann. / Inteso per il Monouso. NON RIUTILIZZARE. Il

riutilizzo e/o il riconfezionamento possono esporre a rischio d’infezione il paziente o l’utilizzatore, compromettere l’integrità strutturale e/o speciche

caratteristiche dei materiali o costruttive del dispositivo, inciandone il corretto funzionamento, e/o causando danni, lesioni, o morte per il paziente.

/ Pensado para un solo uso. NO DEBE REUTILIZARSE. La reutilización o reembalaje podría provocar riesgo de infección en el paciente o el usuario,

podría comprometer la integridad estructural y/o las características esenciales de material y diseño del dispositivo, lo que podría acarrear fallos en el

dispositivo y/o daños, enfermedad e incluso la muerte del paciente. / Bedoeld voor eenmalig gebruik. NIET OPNIEUW GEBRUIKEN. Opnieuw gebruiken

en/of opnieuw verpakken kan het risico op infectie van de patiënt of de gebruiker creëren, de structurele integriteit en/of essentieel materiaal en

ontwerpkarakteristieken van het instrument in gevaar brengen, wat kan leiden tot storing van het instrument, en/of tot letsel, ziekte of de dood van

de patiënt. / Indicado para uma única utilização. NÃO REUTILIZAR. A reutilização e/ou re-embalagem pode criar um risco de infecção no paciente ou

no utilizador, comprometer a integridade estrutural e/ou as características essenciais de design ou material do dispositivo, o que poderá dar origem

a falha do dispositivo e/ou lesão, doença ou morte do paciente. / Προορίζεται για μία μόνο χρήση. ΜΗΝ ΕΠΑΝΑΧΡΗΣΙΜΟΠΟΙΕΙΤΕ. Η επανάχρηση ή/

και η επανασυσκευασία μπορεί να επιφέρουν κίνδυνο μόλυνσης τού ασθενή ή τού χειριστή, να υποσκάψουν τη δομική αρτιότητα ή/και τα βασικά

υλικά και σχεδιαστικά χαρακτηριστικά της συσκευής, γεγονός το οποίο μπορεί να την οδηγήσει σε βλάβη ή/και να προκαλέσουν τραυματισμό,

ασθένεια ή θάνατο του ασθενή. / Beregnet til engangsbrug. MÅ IKKE GENBRUGES. Genbrug og/eller ompakning kan forøge risikoen for infektion hos

patienten/brugeren, kompromittere den strukturelle integritet og/eller enhedens essentielle materiale- og designkarakteristika, hvilket kan føre til

enhedsfejl og/eller beskadigelse, sygdom eller patientens død. / Endast avsedd för engångsbruk. FÅR INTE ÅTERANVÄNDAS. Återanvändning och/eller

omförpackning utsätter både patient och användare för en infektionsrisk samt äventyrar instrumentets strukturella integritet och/eller grundläggande

material- och designegenskaper, vilket kan leda till fel på instrumentet och/eller till patientskada, sjukdom eller dödsfall. / Tarkoitettu kertakäyttöön. EI

SAA KÄYTTÄÄ UUDELLEEN. Uudelleen käyttö ja/tai pakkaus voivat aiheuttaa potilaan tai käyttäjän infektioriskin sekä vaarantaa laitteen rakenteellisen

eheyden ja/tai oleelliset materiaali- ja malliominaisuudet, mikä voi johtaa laitevikaan ja/tai potilaan loukkaantumiseen, sairastumiseen tai kuolemaan.

/ Kun beregnet til engangsbruk. MÅ IKKE BRUKES PÅ NYTT. Gjenbruk og/eller ny innpakning kan skape en risiko for infeksjon av pasient eller bruker,

reduserer den strukturelle integriteten og/eller betydelige designegenskaper for innretningen, noe som kan føre til at innretningen svikter og/

eller føre til skade, sykdom eller død for pasienten. / Egyszer használható termék. NE HASZNÁLJA ÚJRA. A termék ismételt felhasználása és/vagy

újracsomagolása újrafertőződési kockázatot jelenthet a páciens vagy a felhasználó számára, ronthatja a szerkezeti egységet és/vagy a termék alapvető

anyagait és tervezési karakterisztikáját, mely a készülék meghibásodásához és/vagy személyi sérüléshez, megbetegedéshez vagy halálhoz vezethet.

/ Určeno pro jednorázové použití. NEPOUŽÍVEJTE ZNOVU. Opětovné používání a/nebo opětovné zabalování může vytvořit riziko infekce u pacienta

nebo uživatele, oslabit strukturní integritu a/nebo nezbytné vlastnosti materiálu a designu zařízení, což může vést k závadě zařízení a/nebo ke zranění,

onemocnění nebo úmrtí pacienta. / Przeznaczone do jednorazowego użytku. NIE UŻYWAĆ PONOWNIE. Ponowne użycie i/lub przepakowanie może

stwarzać ryzyko zakażenia pacjenta lub użytkownika oraz pogorszyć strukturalną integralność i/lub podstawowe cechy materiałowe i konstrukcyjne

urządzenia, co może spowodować uszkodzenie urządzenia i/lub doprowadzić do obrażeń ciała, choroby lub śmierci pacjenta. / Yalnızca Tek

Kullanımlıktır. YENİDEN KULLANMAYIN. Yeniden kullanmak ve/veya yeniden paketlemek hastaya bir risk veya kullanıcıya bir enfeksiyon oluşturabilir,

cihazın yapısal bütünlüğüne ve/veya asli malzeme ve tasarım özelliklerini bozabilir, bu da cihazın arızalanmasına ve/veya hastanın yaralanmasına,

hastalanmasına veya ölmesine neden olabilir. / Предназначено для одноразового использования. ПОВТОРНОЕ ИСПОЛЬЗОВАНИЕ ЗАПРЕЩАЕТСЯ.

Повторное использование или переупаковка могут создать угрозу инфицирования пациента или пользователя, нарушить структурную целостность

и основные характеристики материалов и конструкции устройства, что может привести к отказу устройства, либо привести к травме, болезни или

смерти пациента.

• 1 •

NEW IMPORTANT INFORMATION:

Recommended Flushing/Maintenance Procedure(s)

The catheter should be maintained in accordance with standard hospital protocols.

Recommended catheter flushing/maintenance is as follows:

1. Flush the catheter after every use, or at least weekly when not in use. Use a 10 ml or larger

syringe.

2. Flush the catheter with a minimum of 10 ml of 0.9% sodium chloride, using a “pulse” or “stop/

start” technique. Use of heparinized saline to lock each lumen of the catheter is optional.

3. Disconnect the syringe and attach a sterile end cap to the catheter hub and tighten securely.

4. Prior to blood sampling when infusing TPN, follow routine maintenance procedure except use

20 ml saline and flush to clear TPN from the catheter.

5. If resistance is met when flushing, no further attempts should be made. Further flushing

could result in catheter rupture with possible embolization. Refer to institution protocol for

clearing occluded catheters.

NOTE: When injecting or infusing medications that are incompatible, you should always flush the

catheter with a minimum of 10 ml saline before and after each medication.

NOTE: When maintained in accordance with these instructions, the PowerPICC SOLO*2

catheter does not require the use of heparinized saline to lock the catheter lumens. However,

use of heparinized saline will not adversely affect the catheter and may be necessary based on

patient status or use of alternate flushing and locking techniques.

Caution: Always remove needles or syringes slowly while injecting the last 0.5 ml of saline.

Caution: Use aseptic techniques whenever the catheter lumen is opened or connected to other

devices.

Caution: The PowerPICC SOLO*2 catheter is designed for use with needleless injection caps

or “direct-to-hub” connection technique. Apply a sterile end cap on the catheter hub to prevent

contamination when not in use. Use of a needle longer than 1.6 cm may cause damage to

the valve.

Warning: Alcohol should not be used to lock, soak or declot polyurethane PICCs because

alcohol is known to degrade polyurethane catheters over time with repeated and prolonged

exposure.

Product Description

A family of peripherally inserted central catheters made from specially formulated and processed

medical grade materials. Each PowerPICC SOLO*2 catheter has a kink resistant, reverse tapered

design. Catheters are packaged in a tray with accessories for reliable long (greater than 30 days) or

short (less than 30 days) term vascular access.

Sterilized by ethylene oxide. Do not re-sterilize.

PowerPICC SOLO*2 Catheter Valve Function

The PowerPICC SOLO*2 catheter valve controls the flow of fluids to provide clamp-free infusion therapy.

Positive pressure into the catheter (gravity, pump, syringe) will open the valve, allowing fluid infusion.

When negative pressure (aspiration) is applied, the valve opens allowing for the withdrawal of blood into

a syringe.

Indications

The PowerPICC SOLO*2 catheter is indicated for short or long term peripheral access to the central

venous system for intravenous therapy, power injection of contrast media, and allows for central venous

pressure monitoring. For blood sampling, infusion, or therapy use a 4 French or larger catheter. The

maximum recommended infusion rate is 5 ml/sec for power injection of contrast media. For central

venous pressure monitoring, it is recommended that a catheter lumen of 20 gauge or larger be used.

Contraindications

The device is contraindicated whenever:

• Thepresenceofdevice-relatedinfection,bacteremia,orsepticemiaisknownorsuspected.

• Thepatient’sbodysizeisinsufficienttoaccommodatethesizeoftheimplanteddevice.

• Thepatientisknownorissuspectedtobeallergictomaterialscontainedinthedevice.

• Pastirradiationofprospectiveinsertionsite.

• Previousepisodesofvenousthrombosisorvascularsurgicalproceduresattheprospective

placement site.

• Localtissuefactorswillpreventproperdevicestabilizationand/oraccess.

Warnings

General Warnings

• WhenusingalcoholoralcoholcontainingantisepticswithpolyurethanePICCs,careshouldbe

taken to avoid prolonged or excessive contact. Solutions should be allowed to completely dry

before applying an occlusive dressing. Chlorhexidine gluconate and/or povidone iodine are the

suggested antiseptics to use.

• Alcoholshouldnotbeusedtolock,soakordeclotpolyurethanePICCsbecausealcoholisknown

to degrade polyurethane catheters over time with repeated and prolonged exposure.

• Donotusethecatheterifthereisanyevidenceofmechanicaldamageorleaking.Damagetothe

catheter may lead to rupture, fragmentation, possible embolism, and surgical removal.

• Ifsignsofextravasationexist,discontinueinjections.Beginappropriatemedicalintervention

immediately.

• Donotwipethecatheterwithacetonebasedsolutionsorpolyethyleneglycolcontainingointments.

These can damage the polyurethane material if used over time.

• IntendedforSinglePatientUse.DONOTREUSE.ThePowerPICC SOLO*2 catheter is a single

use device and should never be re-implanted. Reuse carries with it the attendant concern of

cross-infection regardless of the cleaning or sterilization

method. Re-sterilization of incompletely cleaned devices may not be effective. Any device that has

been contaminated by blood must not be reused or re-sterilized.

• Afteruse,thisproductmaybeapotentialbiohazard.Handleanddiscardinaccordancewith

accepted medical practice and applicable local, state and federal laws and regulations.

• Thefluidlevelinthecatheterwilldrop(allowingairentry)ifthecatheterconnectorisheldabove

thelevelofthepatient’sheartandopenedtoair.Tohelppreventadropinthefluidlevel(allowing

airentry)whilechanginginjectioncaps,holdtheconnectorbelowthelevelofthepatient’sheart

before removing the injection cap.

• CVPMonitoringshouldalwaysbeusedinconjunctionwithotherpatientassessmentmetricswhen

evaluating cardiac function.

Placement Warnings

• Ifthearteryisentered,withdrawtheneedleandapplymanualpressureforseveralminutes.

• Placeafingerovertheorificeofthesheathtominimizebloodlossandriskofairaspiration.The

risk of air embolism is reduced by performing this part of the procedure with the patient performing

theValsalvamaneuveruntilthecatheterisinsertedintothesheath.

• Thisisnotarightatriumcatheter.Avoidpositioningthecathetertipintherightatrium.Placement

or migration of the catheter tip into the right atrium may cause cardiac arrhythmia, myocardial

erosion or cardiac tamponade. The risk of these complications may be more likely in neonatal

patients.

Power Injection Warnings

• Exceedingthemaximumflowrateof5ml/sec,orthemaximumpressureofpowerinjectorsof300

psi, may result in catheter failure and/or catheter tip displacement.

• Failuretoensurepatencyofthecatheterpriortopowerinjectionstudiesmayresultincatheter

failure.

• Failuretowarmcontrastmediatobodytemperaturepriortopowerinjectionmayresultincatheter

failure.

• Useoflumensnot marked “Power Injectable” for power injection of contrast media may cause

failure of the catheter.

• Powerinjectormachinepressurelimitingfeaturemaynotpreventover-pressurizationofan

occluded catheter, which may cause catheter failure.

• PowerPICC SOLO*2catheterindicationforpowerinjectionofcontrastmediaimpliesthecatheter’s

ability to withstand the procedure, but does not imply appropriateness of the procedure for a

particular patient. A suitably trained clinician is responsible for evaluating the health status of a

patient as it pertains to a power injection procedure.

Precautions

General Precautions

• Sterilizedbyethyleneoxide.Donotre-sterilize.

• Carefullyreadandfollowallinstructionspriortouse.

• Federal(U.S.A.)lawrestrictsthisdevicetosalebyorontheorderofaphysician.

• Onlyqualifiedhealthcarepractitionersshouldinsert,manipulateandremovethesedevices.

• FollowUniversalPrecautionswheninsertingandmaintainingthecatheter.

• Followallcontraindications,warnings,cautions,precautionsandinstructionsforallinfusates,

including contrast media, as specified by their manufacturer.

• Precautionsareintendedtohelpavoidcatheterdamageand/orpatientinjury.

• Tominimizetheriskofcatheterbreakageandembolization,thecathetermustbesecuredinplace.

• Alwaysremoveneedlesorsyringesslowlywhileinjectingthelast0.5mlofsaline.

• Acetoneandtinctureofiodineshouldnotbeused.

• Useaseptictechniqueswheneverthecatheterlumenisopenedorconnectedtootherdevices.

• Examinethepackagecarefullybeforeopeningtoconfirmitsintegrityandthattheexpirationdate

has not passed. The device is supplied in a sterile package and is non-pyrogenic. Do not use if

package is damaged, opened or the expiration date has passed.

• Inspectkitforinclusionofallcomponents.

• Flushthecatheterwithsterilenormalsalinepriortouse.Catheterstyletmustbewettedpriorto

stylet repositioning or withdrawal.

• Accessoriesandcomponentsusedinconjunctionwiththisdeviceshouldincorporateluerlock

connections.

• DONOTUSEASYRINGESMALLERTHAN10ml.Prolongedinfusionpressuregreaterthan25

psi may damage blood vessels or viscus.

Precautions Related to Device Placement Procedure

• ThePowerPICC SOLO*2 catheter features a reverse-taper catheter design. Placement of

larger catheters at or below antecubital fossa may result in an increased incidence of phlebitis.

Placement of the PowerPICC SOLO*2 catheter above antecubital fossa is recommended.

• Avoidplacementorsecurementofthecatheterwherekinkingmayoccur,tominimizestressonthe

catheter, patency problems or patient discomfort.

• Donotcutstylet.

• Donotadvancetheguidewirepasttheaxillawithoutfluoroscopicguidanceorothertiplocating

methods.

• Iftheguidewiremustbewithdrawnwhiletheneedleisinserted,removeboththeneedleandwire

as a unit to prevent the needle from damaging or shearing the guidewire.

• Neveruseforcetoremovethestylet.Resistancecandamagethecatheter.Ifresistanceor

bunching of the catheter is observed, stop stylet withdrawal and allow the catheter to return to

normal shape. Withdraw both the catheter and stylet together approximately 2 cm and reattempt

styletremoval.Repeatthisprocedureuntilthestyletiseasilyremoved.Oncethestyletisout,

advance the catheter into the desired position.

• Avoidaccidentaldevicecontactwithsharpinstrumentsandmechanicaldamagetothecatheter

material. Use only smooth-edged atraumatic clamps or forceps.

• Avoidperforating,tearingorfracturingthecatheterwhenusingaguidewire.

• Donotusethecatheterifthereisanyevidenceofmechanicaldamageorleaking.

• Avoidsharporacuteanglesduringimplantationwhichcouldcompromisethepatencyofthe

catheter lumen.

• ThePowerPICC SOLO*2 catheter is designed for use with needleless injection caps or “direct-to-

hub” connection technique. Apply a sterile end cap on the catheter hub to prevent contamination

when not in use. Use of a needle longer than 1.6 cm may cause damage to the valve.

Possible Complications

The potential exists for serious complications including the following:

• AirEmbolism

• Bleeding

• BrachialPlexusInjury

• CardiacArrhythmia

• CardiacTamponade

• CatheterErosionThroughtheSkin

• CatheterEmbolism

• CatheterOcclusion

• CatheterRelatedSepsis

• Endocarditis

• ExitSiteInfection

• ExitSiteNecrosis

• Extravasation

• FibrinSheathFormation

• Hematoma

• IntoleranceReactiontoImplantedDevice

• LacerationofVesselsorViscus

• MyocardialErosion

• PerforationofVesselsorViscus

• Phlebitis

• SpontaneousCatheterTipMalpositionor

Retraction

• Thromboembolism

• VenousThrombosis

• VesselErosion

• RisksNormallyAssociatedwithLocalor

GeneralAnesthesia,Surgery,andPost-

OperativeRecovery

English

• 2 •

Insertion Instructions

1. Identify the Vein and Insertion Site

A. Apply a tourniquet above the anticipated insertion site.

B. Selectaveinbyassessingpatientanatomyandcondition.Recommendedveinsarecephalic,

basilic or median cubital basilic. Caution: The PowerPICC SOLO*2 catheter features a

reverse-taper catheter design. Placement of larger catheters at or below antecubital fossa

may result in an increased incidence of phlebitis. Placement of PowerPICC SOLO*2 catheter

above antecubital fossa is recommended.

C. Release tourniquet.

D. Set up the sterile field.

2. Preflush the Catheter and Stylet

A. Flush the catheter with heparinized saline solution or sterile

normal saline. Note: The catheter may be trimmed if a

shorter length is required.

Optional: For use only when the catheter is not inserted using the over the wire insertion technique.

B. AttachasyringewithsterilenormalsalinetotheLuerLockfittingoftheflushthroughstylet

hub.

C. Inject enough solution to wet the stylet surface entirely. This will activate the hydrophyllic

coating, making the stylet surface very lubricious.

D. Remove the stylet from its holder and insert it into the catheter. If the catheter has been

trimmed, only advance the stylet to the distal end of the catheter. Note: If the surface of the

stylet becomes dry after removal from the holder, wetting with additional sterile normal saline

will renew the hydrophyllic effect.

E. The catheter stylet assembly can now be introduced as described in the following information.

3. Apply Tourniquet and Drape

A. Position arm at 90° angle.

B. Re-applythetourniquetabovetheintendedinsertionsitetodistendthevessel.

C. Prepare the site according to institution policy using sterile technique.

D. Drape the patient by placing the fenestrated drape over the anticipated puncture site.

E. When alcohol is used as a skin prep, it must be allowed to completely air dry.

4. Perform Venipuncture

A. Remove the needle guard and attach a syringe.

B. Introducetheneedleintothevesselandobserveforflashback.

C. When the vein has been entered, remove the syringe leaving

the needle in place.

WARNING: Place a finger over the orifice of the sheath to

minimize blood loss and risk of air aspiration. The risk of air

embolism is reduced by performing this part of the procedure

withthepatientperformingtheValsalvamaneuveruntilthe

catheter is inserted into the sheath. Caution: Avoid placement or securement of the catheter

where kinking may occur, to minimize stress on the catheter, patency problems or patient

discomfort. Caution: The PowerPICC SOLO*2 catheter features a reverse-taper catheter

design. Placement of larger catheters at or below antecubital fossa may result in an increased

incidence of phlebitis. Placement of the PowerPICC SOLO*2 catheter above antecubital fossa

is recommended.

5. Advance Guidewire

A. Introduce the guidewire through the needle; advance the

guidewire 15 to 20 cm into the vessel. Caution: Do not advance

the wire past the axilla without fluoroscopic guidance or other tip

locating methods.

6. Remove Needle

A. Release tourniquet. Apply slight pressure on the vessel above

the insertion site to minimize blood flow.

B. Ifnecessary,enlargethepuncturesitewitha#11scalpelblade.

C. Leavingtheguidewireinplace,withdrawtheneedle.

7. Introduce Microintroducer

A. Introduce the microintroducer assembly over the guidewire.

Using a twisting motion, advance the assembly into the

vessel.

8. Measure Distance to Tip Location

A. Using fluoroscopic control, determine the correct catheter length by

advancingtheguidewiretothedesiredcathetertiplocationintheSVC.

B. Oncetheguidewiretipisinproperposition,markthelengthby

clamping forceps onto the guidewire at the skin site.

9. Removing Dilator and Guidewire

A. Rotate locking collar of dilator and remove dilator from sheath.

B. Withdrawthedilatorandguidewire,leavingthesmallsheathin

place.

WARNING: Place a finger over the sheath opening to minimize

blood loss and risk of air aspiration. The risk of air embolism is

reduced by performing this part of the procedure with the patient

performingtheValsalvamaneuveruntilthecatheterisinsertedinto

the sheath.

10. Modification of Catheter Length

Note: Catheters can be cut to length if a different length is desired due to patient size and desired

point of insertion according to hospital protocol. Catheter depth markings are in centimeters.

A. Measurethedistancefromtheinsertionsite(zeromark)tothedesiredtiplocation.

B. Usingtheguidewiretoindicatedesiredlength,retractthestyletbehindthepointthecatheteris

to be cut (if applicable).

C. Using a sterile scalpel or scissors, carefully cut the catheter according to institutional policy if

necessary.

Caution: Do not cut stylet.

D. Inspect cut surface to assure there is no loose material.

E. Re-advance the stylet to the distal end of the trimmed catheter (if applicable).

11. Insert and Advance the Catheter

A. Insert the catheter (and stylet, if applicable) into the microintroducer

sheath.

B. Advancethecatheterslowly.

C. Stabilize the catheter position by applying pressure to the vein distal to

the microintroducer sheath.

D. Withdraw the microintroducer sheath from the vein and away from

the site.

E. Split the microintroducer sheath and peel it away from the catheter.

12. Complete Catheter Insertion

A. Continue to advance the catheter. For central placement, when the

tip has advanced to the shoulder, have the patient turn head (chin

on shoulder) toward the insertion side to prevent possible cannulation into the jugular vein.

Caution: The PowerPICC SOLO*2 catheter features a reverse-taper catheter design.

Placement of larger catheters at or below antecubital fossa may result in an increased

incidence of phlebitis. Placement of the PowerPICC SOLO*2 catheter above antecubital fossa

is recommended.

B. Positionthearmata90°angle,maintainingsterility.Complete

catheter advancement into the desired position (zero mark).

WARNING: This is not a right atrium catheter. Avoid positioning

the catheter tip in the right atrium. Placement or migration of the

catheter tip into the right atrium may cause cardiac arrhythmia,

myocardial erosion or cardiac tamponade. The risk of these

complications may be more likely in neonatal patients.

C. Stabilize the catheter position by applying light pressure to the vein

distal to the insertion site. Slowly remove the stylet, if applicable

D. Place a finger over the catheter opening to minimize blood loss.

13. Aspirate and Flush

A. Attach primed extension set and/or saline-filled syringe.

B. Aspirate for adequate blood return and flush catheter with 10 ml normal saline to ensure

patency.

Caution: The PowerPICC SOLO*2 catheter is designed for use with needleless injection caps

or “direct-to-hub” connection technique. Apply a sterile end cap on the catheter hub to prevent

contamination when not in use. Use of a needle longer than 1.6 cm may cause damage to

the valve. Caution: Always remove needles or syringes slowly while injecting the last 0.5 ml

of saline.

C. Cap catheter.

WARNING: The fluid level in the catheter will drop if the catheter connector is held above the

levelofthepatient’sheartandopenedtoair.Tohelppreventadropinthefluidlevel(allowing

airentry)whilechanginginjectioncaps,holdtheconnectorbelowthelevelofthepatient’s

heart before removing the injection cap.

14. Dress Catheter

StatLock* Catheter Stabilization Device Procedure

Single Lumen

1. Secure catheter with StatLock

catheter stabilization device.

2. Cover site and StatLock* catheter stabilization device with transparent dressing.

3. Place anchor tape sticky side up, under hub. Wedge tape between hub and wings.

4. Chevron anchor tape on top of transparent dressing.

Dual Lumen

1. Secure catheter with StatLock* catheter stabilization device.

Cover site and

StatLock

catheter stabilization device

with transparent dressing.

Place 1st anchor tape sticky side up, under one extension leg. Wedge tape between hub and wings.

Chevron anchor tape on top of transparent dressing.

Place 2nd anchor tape sticky side up under hub. Wedge tape between hub and wings. Chevron anchor

tape on top of transparent dressing.

Triple Lumen

Secure catheter with

StatLock

catheter stabilization device

Cover site and

StatLock

catheter stabilization device

with transparent dressing.

3. Place 1st anchor tape sticky side up, under one extension leg. Wedge tape between hub and

wings. Chevron anchor tape on top of transparent dressing.

4. Place 2nd and 3rd anchor tapes sticky side up under remaining hubs. Wedge tape between hubs

and wings. Chevron anchor tape on top of transparent dressing.

Zero mark

• 3 •

Tape Strip Securement Procedure

Single Lumen

Dual Lumen

Place 1st anchor tape over wings or bifurcation.

Cover site and 1st anchor tape with transparent dressing up to hub, but not over hub.

Place 2nd anchor tape sticky side up under hub and close to transparent dressing. Wedge tape between

hub and wings. Anchor only one hub of dual lumen catheter.

Chevron 2nd anchor tape on top of transparent dressing and place 3rd anchor tape over hub.

Caution: The catheter must be secured in place to minimize the risk of catheter breakage and

embolization.

WARNING: When using alcohol or alcohol containing antiseptics with polyurethane PICCs, care

should be taken to avoid prolonged or excessive contact. Solutions should be allowed to completely

dry before applying an occlusive dressing. Chlorhexidine gluconate and/or povidone iodine are the

suggested antiseptics to use.

WARNING: Alcohol should not be used to lock, soak or declot polyurethane PICCs because

alcohol is known to degrade polyurethane catheters over time with repeated and prolonged

exposure.

WARNING: Acetone and polyethylene glycol containing ointments should not be used with

polyurethane catheters, as these may damage the device.

Triple Lumen

1. Place 1st anchor tape over wings or trifurcation.

2. Cover site and 1st anchor tape with transparent dressing up to hub, but not over hub.

3. Place 2nd anchor tape sticky side up under hub and close to transparent dressing. Wedge tape

between hub and wings. Chevron anchor tape on top of transparent dressing.

4. Place 2nd and 3rd anchor tapes sticky side up under remaining hubs. Wedge tape between hubs

and wings. Chevron anchor tape on top of transparent dressing.

15. Verify Placement

•PICCsshouldbepositionedwiththecathetertipinthelower1/3oftheSVC.Verifycorrect

catheter tip position using radiography or appropriate technology.

16. Power Injection Procedure

WARNING: PowerPICC SOLO*2 catheter indication for power injection of contrast media implies

thecatheter’sabilitytowithstandtheprocedure,butdoesnotimplyappropriatenessofthe

procedure for a particular patient. A suitably trained clinician is responsible for evaluating the

health status of a patient as it pertains to a power injection procedure.

A. Removetheinjection/needlelesscapfromthePowerPICCSOLO*2catheter.

B. Attacha10mlorlargersyringefilledwithsterilenormalsaline.

C. Aspirate for adequate blood return and vigorously flush the catheter with the full 10 ml of sterile

normal saline. WARNING: Failure to ensure patency of the catheter prior to power injection

studies may result in catheter failure.

D. Detach syringe.

E. AttachthepowerinjectiondevicetothePowerPICCSOLO*2catheterpermanufacturer’s

recommendations.

F. Contrast media should be warmed to body temperature prior to power injection.

WARNING: Failure to warm contrast media to body temperature prior to power injection may

result in catheter failure.

G.Useonlylumensmarked“PowerInjectable”forpowerinjectionofcontrastmedia.

WARNING: Use of lumens not marked “Power Injectable” for power injection of contrast media

may cause failure of the catheter.

H. Complete power injection study taking care not to exceed the flow rate limits. Do not exceed

the maximum flow rate of 5ml/sec.

WARNING: Exceeding the maximum flow rate of 5 ml/sec, or the maximum pressure of power

injectors of 300 psi, may result in catheter failure and/or catheter tip displacement.

WARNING: Power injector machine pressure limiting feature may not prevent over-

pressurization of an occluded catheter, which may cause catheter failure.

I. Disconnect the power injection device.

J. Replace the injection/needleless cap on the PowerPICC SOLO*2 catheter.

K. Flush the PowerPICC SOLO*2 catheter with 10 ml of sterile normal saline, using a 10 ml or

larger syringe. Use of heparinized saline to lock each lumen of the catheter is optional.

• ThePowerPICC SOLO*2 catheter testing included 10 power injection cycles.

17. Suggested Catheter Maintenance

A. Dressing Changes

1. Assess the dressing in the first 24 hours for accumulation of blood, fluid or moisture

beneath the dressing. During all dressing changes, assess the external length of the

catheter to deter mine if migration of the catheter has occurred. Periodically confirm

catheter placement, tip location, patency and security of dressing.

2. Maintainaccordingtohospitalprotocol.Avoidusingacetonebasedsolutions,orointment.

These substances are known to degrade polyurethane.

3. Chlorhexidine gluconate is the suggested antiseptic to use. 2% Chlorhexidine gluconate

/70% isopropyl alcohol swab sticks may be used for dressing changes. Povidone-iodine

may also be used as an antiseptic.

4. Allow all cleaning agents / antiseptics to dry completely before applying dressing. Caution:

Acetone and tincture of iodine should not be used. WARNING: When using alcohol or

alcohol containing antiseptics with polyurethane PICCs, care should be taken to avoid

prolonged or excessive contact. Solutions should be allowed to completely dry before

applying an occlusive dressing. Chlorhexidine gluconate and/or povidone iodine are the

suggested antiseptics to use.

B. Flushing

1. Flush the catheter after every use, or at least weekly when not in use. Use a 10 ml or

larger syringe.

2. Flush the catheter with a minimum of 10 ml of 0.9% sodium chloride, using a “pulse” or

“stop/start” technique. Use of heparinized saline to lock each lumen of the catheter is

optional.

3. Disconnect the syringe and attach a sterile end cap to the catheter hub and tighten

securely.

4. Prior to blood sampling when infusing TPN, follow routine maintenance procedure except

use 20 ml saline and flush to clear TPN from the catheter.

5. If resistance is met when flushing, no further attempts should be made. Further flushing

could result in catheter rupture with possible embolization. Refer to institution protocol

forclearingoccludedcatheters.NOTE:Wheninjectingorinfusingmedicationsthatare

incompatible, you should always flush the catheter with a minimum of 10 ml saline before

andafterthemedication.NOTE:Whenmaintainedinaccordancewiththeseinstructions,

thePowerPICCSOLO*2catheterdoesnotrequiretheuseofheparinizedsalinetolock

the catheter lumens. However, use of heparinized saline will not adversely effect the

catheter and may be necessary based on patient status or use of alternate flushing and

locking techniques.

Caution: Always remove needles or needleless caps slowly while injecting the last 0.5 ml

of saline.

Caution: Use aseptic techniques whenever the catheter lumen is opened or connected to

other devices.

Caution: ThePowerPICCSOLO*2catheterisdesignedforusewithaneedlelessinjection

caps or “direct-to-hub” connection technique. Apply a sterile end cap on the catheter hub

to prevent contamination when not in use. Use of a needle longer than 1.6 cm may cause

damage to the valve. WARNING: Alcohol should not be used to lock, soak or declot

polyurethane PICCs because alcohol is known to degrade polyurethane catheters over

time with repeated and prolonged exposure.

C. Occluded or Partially Occluded Catheter

Catheters that present resistance to flushing and aspiration may be partially or completely

occluded. Do not flush against resistance. If the lumen will neither flush nor aspirate and it

has been determined that the catheter is occluded with blood, a declotting procedure per

institution protocol may be appropriate.

D. When Cleaning the Exit Site

WARNING: Do not wipe the catheter with acetone based solutions or polyethylene glycol

containing ointments. These can damage the polyurethane material if used over time.

•Maintainaccordingtohospitalprotocol.Avoidusingacetonebasedsolutions,orointment.

These substances are known to degrade polyurethane.

•Usechlorhexidinegluconateorpovidioneiodinetocleantheexitsitearoundthecatheter.

•Allowallcleaningagents/antisepticstodrycompletelybeforeapplyingdressing.

18. Central Venous Pressure Monitoring

 •Priortoconductingcentralvenouspressure(CVP)monitoring:

 •Ensureproperpositioningofthecathetertip.

 •Flushcathetervigorouslywithsterilenormalsaline.

 •Ensurethepressuretransducerisattheleveloftherightatrium.

 •Itisrecommendedthatacontinuousinfusionofsaline(3ml/hr)ismaintainedthroughthe

catheterwhilemeasuringCVPtoimproveaccuracyofCVPresults.

 •Useyourinstitution’sprotocolsforcentralvenouspressuremonitoringprocedures.

WARNING:CVPmonitoringshouldalwaysbeusedinconjunctionwithotherpatientassessment

metrics when evaluating cardiac function.

19. Catheter Removal

 •RemovedressingandStatLock* catheter stabilization device or tape securement strips.

 •Graspcatheternearinsertionsite.

 •Removeslowly.Donotuseexcessiveforce.

 •Ifresistanceisfelt,stopremoval.Applywarmcompressandwait20-30minutes.

 •Resumeremovalprocedure.

 •Examinecathetertiptodeterminethattheentirecatheterhasbeenremoved.

• 4 •

135 cm Guidewire Instructions for use:

* Replaces steps 4-12

I. Perform the Venipuncture

• Removetheneedleguardandattachasyringe.

• Introducetheneedleintothevesselandobserveforflashback.

• Whentheveinhasbeenentered,removethesyringeleavingtheneedleinplace.

• Placeafingerovertheneedletominimizebloodlossandriskofairaspiration.Theriskofair

aspiration is reduced by performing this part of the procedure with the patient holding his breath

until the guidewire is inserted into the needle.

• Releasetourniquet.

II. Hydrate Guidewire

• Injectenoughsolutiontowettheguidewiresurfaceentirely.

III. Advance the Guidewire

• Advancetheguidewirethroughtheneedleand,usingfluoroscopy,advancethetipoftheguidewire

to the desired location of the catheter tip within the vessel. CAUTION: Do not advance the

guidewire past the axilla without fluoroscopic guidance.

IV. Remove the Needle

• Removetheneedle,leavingtheguidewireinplaceinthevessel.Applyslightpressureonthe

vessel above the insertion site, to minimize blood flow.

• Enlargethepuncturesitewitha#11scalpelblade,takingcarenottodamagetheguidewire.

V. Measure the Wire

• Notethedepthmarkingontheguidewireatthepointatwhichthewireexitstheskin.Thisis

thelengthtowhichthecathetershouldbecut.Guidewiredepthmarkingsarein5centimeter

increments.

60cm 55cm 50cm 45cm 40cm 35cm

VI. Modify the Catheter Length

Note: Catheters can be cut to length if a different length is desired due to patient size and

desired point of insertion according to hospital protocol. Catheter depth markings are in

centimeters.

• Usingasterilescalpelorscissorsandnotingthecentimetermarkingsonthecatheter,cutthe

catheter to the length matching the distance indicated by the centimeter markings of the wire.

• Inspectthecutsurfacetoensurethereisnoloosematerial.

VII. Introduce the Sheath Introducer

• Introducethesheath/dilatorassemblyovertheguidewire.Usingatwistingmotion,advancethe

assembly into the vessel.

VIII. Remove the Dilator

• Rotatelockingcollarofdilatorandremovedilatorfromtheintroducersheath.

• Withdrawthedilator,leavingtheintroducersheathandguidewireinplace.

WARNING: Place a finger over the opening of the introducer sheath to minimize blood loss

and risk of air aspiration. The risk of air embolism is reduced by performing this part of the

procedure with the patient performing the Valsalva maneuver.

IX. Insert and Advance the Catheter

• Insertthecatheterslowlyoverthewire,throughtheintroducersheath,andintothevessel.

Advance the catheter tubing until approximately 5 cm remains outside the sheath.

X. Retract and Remove the Microintroducer Sheath

• Stabilizethecatheterpositionbyapplyingpressuretotheveindistaltothemicrointroducersheath.

• Withdrawthemicrointroducersheathfromtheveinandawayfromthesite.

• Splittheintroducersheathandpeelitawayfromthecatheter.

• Fullyinserttheremainderofthecathetertubingbelowtheskinsurface.

• Underfluoroscopicvisualization,checkcathetertiplocationinthevessel.

• Slowlyremovetheguidewirefromthecatheter.

• Placeafingeroverthecatheteropeningtominimizebloodloss.

* Proceed to step 13

Anissuedorrevisiondatefortheseinstructionsisincludedfortheuser’sinformation.Intheeventtwo

yearshaveelapsedbetweenthisdateandproductuse,theusershouldcontactBardAccessSystems,

Inc. to see if additional product information is available.

Revised date: June 2011

*Bard,PowerPICC,PowerPICCSOLO,StatLock,andThePowerofPurplearetrademarksand/or

registeredtrademarksofC.R.Bard,Inc.

• 69 •

0728019 1106R

ACCESS SYSTEMS

0086

Bard Access Systems, Inc.

605 North 5600 West

Salt Lake City, UT 84116 USA

801-522-5000

EC REP

Bard Limited

Forest House, Brighton Road

Crawley, West Sussex

RH11 9BP UK

www.powerpiccsolo.com

Clinical Information / Ligne directe d’informations cliniques / Hotline für klinische

Informationen / Linea diretta per le informazioni cliniche / Teléfono de información

clínica / Telefonische hulplijn voor klinische informatie / Linha de informações clínicas /

Γραμμή βοηθείας κλινικών πληροφοριών / Hotline for klinisk information / Telefonnummer

för klinisk information / Kliiniset tiedustelut numerosta / klinisk informasjon / Klinikai

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Bard PowerPICC SOLO 2 Instructions For Use Manual

Bard PowerPICC SOLO 2 Instructions For Use Manual

Bard PowerPICC SOLO 2 Instructions For Use Manual

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