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17

INSTRUCTIONS FOR USE  

|  

GB

transrectally at the height of the epigastrium.
Likewise, various surgical techniques are 
available for positioning the peritoneal catheter.
We recommend pulling through the peritoneal 
catheter, using a subcutaneous tunneling tool 
and perhaps with an auxiliary incision, from the 
shunt to the intended position of the catheter. 
The peritoneal catheter, which is usually secu-
rely attached to the 

miniNAV

, has an open distal 

end, but no wall slits. Following the exposure 
of, and the entry into, the peritoneum by means 
of a trocar, the peritoneal catheter (shortened, 
if necessary) is pushed forward into the open 
space in the abdominal cavity.

PREOPERATIVE VALVE TEST

Isotonic sterile sodium chloride solution

Fig. 5: Patency test

The 

miniNAV

 can be filled by aspiration through 

a sterile, single-use syringe attached to the di-
stal end of the catheter. The proximal end of 
the valve is immersed in a sterile, physiological 
saline solution. The valve is patent if fluid can be 
extracted in this way (see Fig. 5).

Caution: Pressure admission through the 
single-use syringe should be avoided, both 
at the proximal and the distal end.
Contaminations in the solution used for the 
test can impair the product’s performance.

SAFETY MEASURES

The patients must be carefully monitored after 
the implantation. Reddened skin and tension in 
the area of the drainage tissue could indicate 
infections at the shunt system. Symptoms such 
as headache, dizzy spells, mental confusion or 
vomiting are common occurrences in cases of 
shunt dysfunction. Such symptoms, as well as 
shunt system leakage, necessitate the imme-

diate replacement of the shunt component re-
sponsible, or of the entire shunt system

RE-IMPLANTATION

Under no circumstances should products that 
have had previously been implanted in a pati-
ent be subsequently reimplanted in another, 
because a successfull decontamination of the 
device cannot be reached without functional 
degradation. 

COMPATIBILITY WITH DIAGNOSTIC PRO-
CEDURES

MRI examinations with field strengths of up to 
3.0 tesla and CT examinations can be carried 
without endangering or impairing the functiona-
lity of the shunt. The 

miniNAV

 is MR Conditional 

(ASTM-F2503-08). All components are visible 
via X-ray. The provided catheters are MRI Safe. 
Reservoirs, deflectors and connectors are MR 
Conditional.

POSTOPERATIVE VALVE TEST

The 

miniNAV

 has been designed as a safe and 

reliable unit even without the implantation of a 
pumping device. However, the inclusion of a 
prechamber or a borehole reservoir allows the 
shunt system to be tested by flushing or pres-
sure measurements.

STERILISATION

The products are sterilized with steam under 
closely monitored conditions. Double wrapping 
in sterile bags ensures sterility for a period of 
five years. The expiry date is printed on the 
wrapping of each individual product. Products 
taken from a damaged wrapping must not be 
used under any circumstances.

RESTERILISATION

The functional safety and reliability of resterilized 
products cannot be guaranteed, therefore re-
sterilisation is not recommended.

Содержание miniNAV

Страница 1: ...discard The Instructions for Use for United States users can be obtained by visiting our website at www aesculapusa com and clicking the Products menu If you wish to obtain a paper copy of the Instru...

Страница 2: ......

Страница 3: ...UF 7 PR OPERATIVE VENTILPR FUNG 8 WIEDERHOLUNGSIMPLANTATIONEN 8 VORSICHTSMASSNAHMEN 8 VERTR GLICHKEIT MIT DIAGNOSTISCHEN VERFAHREN 8 POSTOPERATIVE VENTILPR FUNG 8 FUNKTIONSSICHERHEIT 8 NEBENWIRKUNGEN...

Страница 4: ...vermei den Das miniNAV besteht aus einem stabilen Titangeh use 1 in das das bew hrte Prinzip eines Kugel Konus Ventils integriert ist Eine Spiralfeder 2 bestimmt den ffnungsdruck des Kugel Konus Venti...

Страница 5: ...K rperposition wird der Ven trikeldruck beim gesunden Menschen leicht negativ Um diesen Druck mittels Ventildrainage einzustellen muss der Ventil ffnungsdruck weit h her ausgelegt werden als in der l...

Страница 6: ...Ende und eine konvexe nach au en gew lbt Form am distalen Ende handelt es sich um die Druckstufe 5 cmH2 O Abb 4 Jedes miniNAV wird unter strenger Qualit ts kontrolle kalibriert Die folgenden Druckstuf...

Страница 7: ...ieferten Katheter ver ndern die Druck Flow Charakteristik nicht grundlegend OPERATIONSABLAUF Platzierung des Ventrikelkatheters Zur Platzierung des Ventrikelkatheters sind ver schiedene Operationstech...

Страница 8: ...tungen und Spannungen im Bereich des Drainagege webes k nnen ein Anzeichen von Infektionen am Shuntsystem sein Symptome wie Kopf schmerzen Schwindelanf lle geistige Ver wirrtheit oder Erbrechen treten...

Страница 9: ...olgend sind die Druck Flow Charakteri stiken der verf gbaren Druckstufen des miniNAV dargestellt 5 10 10 20 30 40 0 5 25 15 35 45 50 55 15 20 miniNAV 0 cmH2 O Druck cmH 2 O Flussrate ml h Druckstufe 0...

Страница 10: ...inprodukterichtlinie fordert die um fassende Dokumentation des Verbleibs von medizinischen Produkten die am Menschen zur Anwendung kommen insbesondere f r Implantate Die individuelle Kenn Nummer des i...

Страница 11: ...t unterschiedlichen Komponenten erh ltlich miniNAV miniNAV SHUNTSYSTEM miniNAV SHUNTSYSTEM mit SPRUNG RESERVOIR oder Bohrlochreservoir auch f r p diatrische Anwendung miniNAV SHUNTSYSTEM mit CONTROL R...

Страница 12: ...SURGICAL PROCEDURE 16 PREOPERATIVE VALVE TEST 17 SAFETY MEASURES 17 RE IMPLANTATION 17 COMPATIBILITY WITH DIAGNOSTIC PROCEDURES 17 POSTOPERATIVE VALVE TEST 17 STERILISATION 17 RESTERILISATION 17 PRES...

Страница 13: ...to arise in the treatment of hydrocephalus The miniNAV is composed of a robust titanium casing 1 whose proximal end contains a ball cone valve A spiral spring 2 maintains the opening pressure of the...

Страница 14: ...maintain this pressure by means of shunt drainage the shunt opening pressure has to be significantly higher so that the shunt can com pensate for the hydrostatic pressure minus the sum of the abdomina...

Страница 15: ...g to the shape of the valve s housing For example the miniNAV with an opening pres sure of 5 cmH2 O has a concave proximal part curved inwards and a convex distal part cur ved outwards Fig 4 Each mini...

Страница 16: ...It is essential that kinks in the catheter are avoided The included catheters have virtually no effect on the Pressure flow characteristics SURGICAL PROCEDURE Positioning the ventricular catheter Seve...

Страница 17: ...uch as headache dizzy spells mental confusion or vomiting are common occurrences in cases of shunt dysfunction Such symptoms as well as shunt system leakage necessitate the imme diate replacement of t...

Страница 18: ...for long term reliable and precise operation Still the possi bility that the shunt system will need to be re placed for technical or medical reasons cannot be excluded The valve and the valve system...

Страница 19: ...AG Am Aesculap Platz D 78532 Tuttlingen Phone 49 0 7461 95 0 Fax 49 0 7461 95 26 00 e mail information aesculap de Service address in the US AESCULAP Inc Attn AESCULAP Technical Services 615 Lambert...

Страница 20: ...e valve or as a shunt system comprising various components miniNAV miniNAV SHUNTSYSTEM miniNAV SHUNTSYSTEM with SPRUNG RESERVOIR or with borehole reservoir adult and pediatric miniNAV SHUNTSYSTEM with...

Страница 21: ......

Страница 22: ...ACI N PREQUIR RGICA DE LA V LVULA 27 MEDIDAS DE SEGURIDAD 27 SEGUNDAS IMPLANTACIONES 27 COMPATIBILIDAD CON M TODOS 27 DIAGN STICOS 27 COMPROBACI N POSTQUIR RGICA DE LA V LVULA 27 SEGURIDAD DE FUNCIONA...

Страница 23: ...consiste en una s lida estructura de titanio 1 esta integrada una v lvula de bola en cono Im gen 1 Un resorte en espiral 2 determina la presi n de apertura de la v lvula de bola en cono Una bola de za...

Страница 24: ...presi n fisiol gica mediante una v lvula en un drenaje por deriva ci n la presi n de apertura de la v lvula para la posici n erguida debe ser bastante superi or Solamente de esta forma puede la v lvu...

Страница 25: ...trata de una presi n valvular de 5 cmH2 O Im gen 4 Cada miniNAV se calibra con estrictos con troles de calidad de calidad Presi n de aper tura de la v lvula cmH2 O Codificaci n 0 5 10 15 COMPONENTES...

Страница 26: ...n en la caracter stica de presi n caudal PROCEDIMIENTO QUIR RGICO Colocaci n del cat ter ventricular Para colocar el cat ter ventricular se pueden utilizar distintas t cnicas quir rgicas El corte cut...

Страница 27: ...ser signos de infecci n en el sistema de derivaci n Los s ntomas como dolor de cabeza mareos estados de confusi n o v mitos suelen aparecer en casos de funcio namiento incorrecto del sistema de deriva...

Страница 28: ...o ninguna circunstancia REESTERILIZACI N No se puede garantizar la seguridad de fun cionamiento si los productos son reesteriliza dospor lo que no se recomienda volver a es terilizar VALORES CARACTER...

Страница 29: ...ODUCTOS M DICOS La empresa Christoph Miethke GmbH Co KG designa seg n lo estipulado europeo MDD 93 42 EEC por la Ley de productos m dicos un consultor de productos m dicos que act a como interlocutor...

Страница 30: ...lvula nica o como un sistema de derviaci n que incluye varios componentes miniNAV miniNAV SHUNTSYSTEM miniNAV SHUNTSYSTEM con borehole o SPRUNG RESERVOIR adulto y pedi trico miniNAV SHUNTSYSTEM con C...

Страница 31: ......

Страница 32: ...PROCEDURY OPERACYJNE 36 WYPOSA ENIE NIEZB DNE DO PRZEPROWADZENIA TESTU 37 PRZYGOTOWYWANIE WYPOSA ENIA DO PRZEPROWADZENIA TESTU 37 KALIBROWANIE WYPOSA ENIA DO PRZEPROWADZENIA TESTU 37 PROCEDURA TESTUJ...

Страница 33: ...akie pojawiaja si przy leczeniu wodog owia miniNAV sk ada si z twardej tytanowej obudowy 1 w kt rej w bli szym ko cu umieszczony jest za w r kulka w sto ku Spr ynka spiralna 2 okre la ci nienie otwarc...

Страница 34: ...ekko ujemne Do wyregulowania tego cisnienia przez drena zastawkowy ci nienie otwarcia zastawki musi by znacz co wi ksze aby skompensowa ci nienie hydrostatyczne mi nus suma cisnienia wewn trz jamy brz...

Страница 35: ...nawalne po kszta cie korpu su Np minNAV z ci nieniem otwarcia 5 cmH2O ma wkl s przedni cz kor pusu i wypuk wylotow Ka da zastaw ka minNAV jest kalibrowana zgodnie z wysokojako ciowymi normami Dost pne...

Страница 36: ...nienia wewn trz kom r m zgowych Jest ona dost pna z drenem lub bez zintegrowane go drenu rednica wewn trzna 1 2mm rednica zewn trzna 2 5mm Je eli wybra na zostanie zastawka bez zintegrowanego drenu w...

Страница 37: ...wstrzykiwa p yn w pod ci nieniem do adnego z ko c w zastawki Zanieczyszczenia znajduj ce si w p ynie u ytym do testowania zastawki mog obni a jako funkcjonowania zastawki Nale y upewni si czy zachowan...

Страница 38: ...aworu tak jak to pokazano na Rys 9 W mo mencie ustawienia tr jdro nego zaworu w po danej pozycji poziom wody w manometrze winien zacz opada W tym momencie zastawka i strzykawka s odizolowane od siebie...

Страница 39: ...LERANCJA PROCEDUR DIAGNOSTYCZNYCH Zastawka miniNAV podobnie jak inne elementy systemu zastaw kowego zbudowane s wy cznie z materia w nie magnetycz nych tytan szafir stal nierdzewna i tantal Dzi ki tem...

Страница 40: ...uktach medycznych wymaga odpowiedniej dokumentacji o produktach me dycznych aplikowanych do ludzkiego cia a szczeg lnie w stosunku do implant w Z tego wzgl du indywidualny numer implantowanej zastawki...

Страница 41: ...Zastawka miniNAV jest dost pna jako samod zielna zastawka lub jako system zastawkowy miniNAV miniNAV SHUNTSYSTEM miniNAV SHUNTSYSTEM with SPRUNG RESERVOIR or Borehole Reservoir miniNAV SHUNTSYSTEM wi...

Страница 42: ......

Страница 43: ......

Страница 44: ...Technical alterations reserved Sous r serve de modifications techniques Sujeto a modificationes t cnicas Con riserva di modifiche tecniche 0297 Manufacturer acc MDD 93 42 EEC CHRISTOPH MIETHKE GMBH CO...

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